Clinical Trial News
George Medicines Announces GMRx2 NDA Filing to FDA
George Medicines' GMRx2, a triple combination single pill for hypertension, achieved primary efficacy and safety endpoints in Phase III studies, aiming to transform treatment.
Turn Therapeutics Topical Atopic Dermatitis Candidate Significantly Inhibits Key Cytokines in Expansion Study of Flagship Formula
Turn Therapeutics announced positive data results of GX-03, showing significant inhibition of key cytokines in an eczema model, with a 67.7% reduction in IL-31 levels vs placebo. The candidate also demonstrated a significant reduction in ISGA score to 0.8, indicating clear to almost clear skin condition.
Innovent and SanegeneBio Announce First Participant Dosed in a Phase 1 Clinical Trial of IBI3016
Innovent and SanegeneBio announce the first participant dosed in a Phase 1 clinical trial of IBI3016, an siRNA drug candidate targeting angiotensinogen (AGT) for hypertension treatment, demonstrating significant blood pressure reduction in preclinical studies. The collaboration aims to evaluate IBI3016's safety and efficacy in healthy volunteers and mild hypertension patients, with the potential to offer a more effective and safer treatment option for hypertension patients globally.
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FDA Advisory Committee Votes Favorably that the Data Support Arimoclomol as Effective Treatment for Patients with Niemann-Pick Disease Type C
FDA's GeMDAC voted favorably (11 yes, 5 no) that arimoclomol is effective for Niemann-Pick disease type C (NPC). Zevra Therapeutics remains confident in arimoclomol's clinical benefit and its path to approval, with a PDUFA action date of September 21, 2024.
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IDeate-Lung02 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Patients With Relapsed Small Cell Lung Cancer
The IDeate-Lung02 Phase 3 trial evaluating ifinatamab deruxtecan in relapsed small cell lung cancer has initiated, with the first patient dosed.
FDA Expands Jemperli (dostarlimab-gxly) Plus Chemotherapy Approval to All Adult Patients with Primary Advanced or Recurrent Endometrial Cancer
FDA approves Jemperli plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer, including those with MMRp/MSS tumors, based on RUBY phase III trial results showing significant OS benefit.
BioNTech Announces Positive Topline Phase 2 Results for mRNA Immunotherapy Candidate BNT111 in Patients with Advanced Melanoma
BioNTech announces positive Phase 2 results for mRNA immunotherapy BNT111 in advanced melanoma patients, showing significant improvement in ORR when combined with cemiplimab vs. historical control, with both monotherapies active. BNT111, part of BioNTech's FixVac platform, targets four tumor-associated antigens and has received FDA Fast Track and Orphan Drug designations for melanoma treatment.
Vertex Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain
Vertex's suzetrigine, an oral NaV1.8 pain signal inhibitor, has been accepted by the FDA for priority review to treat moderate-to-severe acute pain, with a PDUFA target action date of January 30, 2025.
Darzalex Faspro (daratumumab and hyaluronidase-fihj)-Based Quadruplet Regimen Approved in the U.S. for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant-Eligible
FDA approves Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation in newly diagnosed multiple myeloma (NDMM) patients eligible for autologous stem cell transplant (ASCT), supported by Phase 3 PERSEUS study data showing significant improvement in progression-free survival (PFS) and deeper responses with D-VRd compared to VRd.
Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia
The FDA extended the PDUFA action date for Syndax Pharmaceuticals' NDA for revumenib, a treatment for relapsed or refractory KMT2Ar acute leukemia, to December 26, 2024, due to a major amendment submission. Revumenib aims to address significant unmet needs in KMT2A-rearranged acute leukemia patients.